Comparison of Alpha Blockers (Terazosin and Tamsulosin) in Reducing Ureteral Stent Related Symptoms
TRAM
Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
2 other identifiers
interventional
150
1 country
2
Brief Summary
The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications. Main objective:
- To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms. Secondary objectives:
- To compare painkiller use among the groups.
- To assess differences in Body pain, General health, Work performance, Sexual matters, and Additional problems using a questionnaire (USSQ).
- To assess differences in side effects. After stent placement, subjects will be randomly assigned to one of three groups:
- Terazosin (alpha-blocker) for 14 days
- Tamsulosin (alpha-blocker) for 14 days
- Standard of care (no alpha-blocker). All subjects will be discharged with standard pain-killers and a diary to track usage. Subjects in Terazosin and Tamsulosin groups will receive respective study medications to complete 14 days course of treatment.
- Day 7: A phone call will check medication use and any side effects.
- Day 15: Clinic visit for stent removal (standard practice). Subjects will complete the USSQ questionnaire, and medication compliance will be reviewed. End of study: Final phone call to check for any additional side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2025
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
September 5, 2025
August 1, 2025
12 months
May 4, 2025
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms
Ureteral Stent Symptom Questionnaire (USSQ)- "Urinary Symptom score" domain. This domain focuses on issues related to urine storage and voiding, including symptoms such as weak stream, intermittent, incomplete empty, straining to start, frequency of spasm, urgency, nocturia, dysuria, hematuria, urge incontinence and impact quality of life. Each symptom is scored, with higher score indicating more severe symptoms. The total score ranges from 11 ( best outcome) to 56 (worst outcome).
From randomization to the end of the treatment at 14 days
Secondary Outcomes (3)
To determine the difference in analgesic requirement
From randomization to the end of the treatment at 14 days
To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting: Body pain, General health Work performance, Sexual matters, Additional problems
From randomization to the end of the treatment at 14 days
To describe the difference in adverse events
From randomization to the end of the treatment at 14 days
Study Arms (3)
Terazosin
EXPERIMENTALTerazosin 2mg ON
Tamsulosin
EXPERIMENTALTamsulosin 0.4mg ON
Standard care
NO INTERVENTIONNo medication
Interventions
Eligibility Criteria
You may qualify if:
- Malaysian age 18 years old and above.
- Able to provide written informed consent to participate in the trial.
- Willing to comply with study procedures.
- Unilateral intracorporeal lithotripsy procedure with ureteral stent placement for uncomplicated ureteric or renal calculi
You may not qualify if:
- Known comorbidity that increase the risk of complication
- Prostate pathology: Benign prostate hyperplasia, prostatitis, prostatic carcinoma
- Bladder pathology: Bladder tumor, stone, overactive bladder
- Ureteral abnormality/ trauma, urethral stricture
- Concomitant urinary tract infection
- Orthostatic hypotension
- Solitary kidney
- Previous pelvic/ gynaecological surgery
- Patient is concomitantly receiving treatment from a pain clinic for chronic pain management.
- Pregnancy (for women of childbearing potential)
- Known history of allergic reactions to tamsulosin or terazosin
- Patient is concomitantly taking warfarin or H2 receptor blockers
- Patients with clinical condition(s) judged by the researcher/ clinician to be unsuitable for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sultanah Bahiyah Hospital, Alor Setar
Alor Star, Kedah, 05460, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10450, Malaysia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
May 4, 2025
First Posted
May 13, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08